histologically confirmed locally advanced breast cancer (> cT2)
Conditions
Sponsors
WSG GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age = 18 years and = 65 years female primary carcinoma of the breast confirmed histologically by core biopsy; solitaire, multi-focal defined as histologically confirmed tumour-manifestations within a quadrant or as distance between tumour-manifestations 60 ml/min Urine dipstick for proteinuria =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Distant metastasis; multicentric tumours; previous breast cancer; inflammatory breast cancer without bi-dimensional measurable lesion; prior or concurrent off-study systemic cancer therapy; pregnant/lactating women; serious illness or medical condition or inadequate bone marrow, hepatic or renal function. Congestive heart failure, unstable angina pectoris, myocardial infarction in the last 12 months, clinical significant valvular heart disease. Incomplete wound healing or unhealed bone fracture. Previous thromboembolic events, coagulopathy with increased bleeding risk. Major surgery within the last 28 days Disease significantly affecting gastrointestinal function, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs) For MRI investigation: Contraindications against Gd-DTPA, e.g. renal failure; allergy against Gd-DTPA; Contraindications against MRI, e.g. cardiac pace maker, artificial heart valves, cerebral clips or clips < 2 months post-surgery, other implants unsuitable for MRI; claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy of cytotoxic-antiangiogenic neoadjuvant therapy in primary breast cancer: bevacizumab+trastuzumab+docetaxel100 for group A (HER2 positive) or bevacizumab+docetaxel100 for group B (HER2 negative) using pathological complete response (pCR) as the primary endpoint. To evaluate the predictive impact of imaging information (FDG PET; MRI and DWI in MRI in correlation with MX; US) concerning response to neoadjuvant cytotoxic-antiangiogenic therapy. Rate of pathologic complete remission (pCR) following neoadjuvant therapy in group A and group B. ;Secondary Objective: Predictive impact of imaging parameters:pre-therapeutic and early-response FDG PET, early-response MRI, DWI and DCE-MRI in correlation with MX,US pretherapeutic, DWI and DCE-MRI in correlation with US 2-3 week measurement, before cycle 2, DWI and DCE-MRI in correlation with unilateral MX, US before surgery Compare disease free survival and overall survival Rate of breast conserving therapy vs. mastectomy Identification of predictive markers in pre-therapeutic core biopsy and serum (Translational);Primary end point(s): unacceptable toxicity intolerable side effects of the study drug pregnancy lack of compliance or medication with interfering drugs any other reason leading the investigator to conclude that continuation is not in the patient’s best interest disease progression or second primary malignancy desired by patient | — |
Countries
Germany
Outcome results
None listed